Atrial Fibrillation
Conditions
Keywords
artificial intelligence
Brief summary
Chang Gung Atrial Fibrillation Detection Software is an artificial intelligence electrocardiogram signal analysis software that detects whether a patient has atrial fibrillation by static 12-lead ECG signals. This study is a non-inferiority test based on the control group. The main purpose is to verify whether Chang Gung atrial fibrillation detection software can correctly identify atrial fibrillation in patients with atrial fibrillation, and can be used to provide a reference for doctors to detect atrial fibrillation.
Detailed description
This study is a retrospective study, and the data is from the six hospitals of Chang Gung Medical Research Database (CGRD). We collected de-identified static 12-lead electrocardiogram (ECG) data from the database during the period of January 1, 2006, to December 31, 2019. We created a training set and a testing set of ECG data from the CGRD. Then, we stratified and sampled ECG signals from the testing set according to the actual proportion to obtain the experimental sample. The computer first preliminarily screened and selected ECG data that met the inclusion and exclusion criteria, and then numbered them sequentially. A cardiologist confirmed that the sampled ECG data did not include exclusion criteria. The ECG data were converted into images and interpreted for the presence or absence of atrial fibrillation by three cardiologists. Their results were used as the gold standard (reference) for this study. After determining the experimental standards, the ECG signals were inputted into the Chang Gung Atrial Fibrillation Detection software for analysis and interpretation of each ECG data. After the software interpretation was completed, the results were compared with the interpretations of the physicians, and the primary and secondary evaluation indicators were analyzed accordingly.
Interventions
DEVICEChang Gung Atrial Fibrillation Detecting Software
This software is expected to be used in clinical testing to interpret the static 12-lead ECG of adults who are over 20 years old and suspected of having atrial fibrillation, detect whether there is a signal of atrial fibrillation, and output the results for clinicians Near-instant auxiliary diagnostic use.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Equal or greater than twenty years old * Static 12-lead electrocardiogram of General Electric MUSE XML format file. * The data comes from the static 12-lead electrocardiogram device of General Electric (model MAC5500). * The electrocardiogram signal is 500 Hz. * The Alternating current (AC) filter of the electrocardiogram signal is 60 Hz.
Exclusion criteria
* Cases used in the model development process. * Lacks any electrode. * Contain any electrode lacks a segment. * Misplaced leads
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | baseline | The rate of test results that correctly indicate the presence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy | baseline | The rate of all test results that correctly indicate. |
| Area Under the receiver operating characteristic Curve | baseline | A graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied. |
| Positive predictive value | baseline | The proportions of positive results in statistics and diagnostic tests that are true positive results |
| Specificity | baseline | The rate of test results that correctly indicate the absence. |
| False positive rate | baseline | The rate of test result which wrongly indicates that a particular condition or attribute is present |
| False negative rate | baseline | The rate of test result which wrongly indicates that a particular condition or attribute is absent |
| Negative predictive value | baseline | The proportions of negative results in statistics and diagnostic tests that are true negative results |
Countries
Taiwan
Outcome results
None listed